# K890925: Manan Bone Marrow Biopsy Needle

- Pathway: 510(k) (Traditional)
- Applicant: Manan Medical Products, Inc.
- Decided: Apr 11, 1989 after 46 days
- Product code: DWO (Needle, Biopsy, Cardiovascular)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
65 later devices descend from it; 3 cite it directly.
1 of 66 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961959: MD Tech Biopsy Set for Bone and Bone Marrow (1996), 35 descendants of its own
- K980196: MD Tech Biopsy Set for Bone and Bone Marrow (1998), 34 descendants of its own
- K990515: Mathis Vertebral and Bone Biopsy System (1999), 30 descendants of its own
- K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits (2003), 29 descendants of its own
- K060148: Ebi Vertebroplasty Systems (2006), 18 descendants of its own

## Recalls of this device
- Dec 18, 2018 · Class II · Z-0814-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Dec 18, 2018 · Class II · Z-0815-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Dec 18, 2018 · Class II · Z-0816-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Dec 18, 2018 · Class II · Z-0817-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Dec 18, 2018 · Class II · Z-0818-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Dec 18, 2018 · Class II · Z-0820-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
- Dec 18, 2018 · Class II · Z-0819-2019: Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line

Source page: https://510kreport.com/device/K890925
Methodology: https://510kreport.com/methodology